Month: August 2016

Boehringer Ingelheim Pharmaceuticals and the Duke Clinical Research Institute have expanded their collaboration to create the largest patient registry for Idiopathic Pulmonary Fibrosis (IPF)The IPF-PRO Registry will be widened to cover 1500 patients spread over 45 clinical sites which will stimulate understanding of disease progression and patient specific disease outcomes.

BioInvent Inks Mfg. Pact with Global Pharma FirmBioInvent, a Sweden based company collaborated with Global Pharma Firm to expand its internal and external projects with an estimate revenue generation of SEK 8million.

Elite Pharma, SunGen Pharma in Development and License Agreement
Elite Pharma, entered into an exclusive licensing agreement with SunGen Pharma for the development and commercialization of its four generic products including two CNS stimulants and two beta blockers. Both the US based companies will have marketing rights to two products each whereas Elite Pharma was granted the responsibility of manufacturing and packaging all the four products.

Boehringer and Saniona to Develop new Compounds for Schizophrenia TreatmentBoehringer has partnered with Saniona for the discovery, development, commercialization and manufacture of drugs related to Schizophrenia. Boehringer will pay upto EUR 90 million inclusive of an upfront payment of EUR 5 million, research, development and regulatory milestone payments of upto EUR 50 million and other royalties of upto EUR 35 million on net sales of the commercialized product under the collaboration.

BioLineRx and I-Bridge Capital Establish a New Drug Development Joint Venture in ChinaBioLineRx and I-Bridge Capital have ventured into iPharma for the development of novel clinical and preclinical therapeutic products in Israel and will provide initial capital of $1 million each. BioLineRx seeks to discover novel therapeutic targets based on Chinese population. The drug will further be in licensed by iPharma for its development and commercialization.

A Research Alliance forms between Harvard and Tata CompaniesTata companies entered a research agreement with Harvard University. The agreement spans a six-year time frame, and has $8.4 million research grant riding on the offer. The boasts of cutting edge research in the labs of the university while keeping the professional development programs under the visiting technology business leaders. This is a unique collaboration, and has been designed to help bring greater benefit of Harvard’s research innovations to the public.

Innovative Targeting Solutions and Johnson & Johnson Innovation collaborate to Advance Drug Discovery
A research collaboration with Janssen Biotech, Inc. (Janssen), was announced by Innovative Targeting Solutions Inc. HuTARG™ research platform of ITS will be utilized by Janssen to discover antibody candidates useful for modulating immune responses in autoimmunity or cancer. The details of the collaboration are not being disclosed at this time.

Mylan’s EpiPen is used as a lifesaver to threatening allergic reactions. It mitigates or reverses allergic reactions including abrupt blocking of airways and swollen legs, chest or neck. In late 2007, Mylan acquired the rights to sell EpiPen, an invention of the 1970s. Even its inventor Sheldon Kaplan did not know its real worth until Mylan hiked its price by 400% in 2016. The present cost of a two pen set has sky rocketed from $100 to $608, which is approximately a six fold increase in the price. This price hike is pushing patients backwards to conventional injections. Currently, around 63,000 people have signed a petition asking Congress to vet the rationality of the price hikes.

In order to combat the wide criticism, Mylan had decided to sell its generic version within a few weeks priced at $300 for a set of two generic pens. Also, it plans to offer $300 from $ 100 out of their pockets as copay schemes. Well, for this generic injection, $304 is it’s the real worth or not, we are yet to find out. The company has thus initiated a competition between its two soaring products. The winner is almost clear to all of us.

Immune checkpoints are defined as the stimulatory or co-stimulatory molecules involved in the immune system. There are two kinds of checkpoint proteins found on T cells such as PD-1/PD-L1 and cytotoxic T lymphocytes (CTLA-4). The PD1/PD-L1 pathway is an adaptive immune resistance mechanism exerted by tumor cells in response to endogenous anti-tumor activity. PD-1, a protein present in humans encoded by the PDCD1 gene, binds to two ligands- PD-L1 and PD-L2 to prevent the activation of T-cells by regulating the immune system. PD-L1 is a protein present in human encoded by CD274 gene that reduces the proliferation of CD8+ T cells at the lymph nodes by binding to PD-1 or B7.

Immune checkpoint inhibitors are type of drugs, usually antibodies, which block these proteins of the immune system cells. Inhibiting the binding of PD-L1 to PD-1 with an immune checkpoint inhibitor leads to killing of tumor cells by T Cells. PD-1 and PD-L1 inhibitors are used as immunotherapy for treating various cancers such as Lung Cancer, Metastatic Renal Cell Carcinoma, Head and Neck Cancer and Melanoma. They also protect against immune-mediated tissue damage.

Currently, there are 3 approved drugs for PD-1 and PDL-1 inhibitors. Tecentriz was the first PDL-1 inhibitor to be approved and other 2 drugs i.e. Opdivo and Keytruda are PD-1 inhibitors.

Opdivo was the first PD-1 inhibitor to be approved in July 2014. It has been approved for the treatment of Advanced Melanoma, Advanced Renal Cell Carcinoma, Hodgkin lymphoma, Non-Small Cell Lung Cancer and Metastatic Keytruda has been approved for the treatment of Advanced Melanoma, Non-Small Cell Lung Cancer and Metastatic Melanoma.

More durable effect on cancer and low toxicity is observed with Tecentriq as compared to other approved drugs.

It is estimated that PD-1 and PDL-inhibitors bring the sales of USD 35 Billion. Opdivo had USD 2.1 billion sales versus Keytruda’s USD 566 million in 2015. It is also estimated that Tecentriq will have blockbuster sales in coming years.

PD-1 and PD-L1 inhibitors have replaced existing chemotherapy and radiotherapy for treating cancer. Several clinical trials for combination therapy of PD-1 and PD-L1 inhibitors are ongoingwith around 245 active clinical studies. The Pipeline of PD-1 and PD-L1 is profuse with approx. 47 drugs with 35 companies involved, including big pharmaceutical companies such as Hoffmann-La Roche, Merck Sharp & Dohme Corp., Pfizer Inc., Bristol-Myers Squibb and AstraZeneca.

The South San Francisco biotech startup, Denali Therapeutics, that had raised $217 million last year to fight Alzheimer’s, Parkinson’s and ALS, and an additional $130 million from investors in a private placement led by Baillie Gifford, a UK-based mutual fund, has finally spoken about its plans to use the fund. The company is based to discover genes that have been implicated in the diseases mentioned. This project is the one that Denali’s CEO and co-founder, Ryan Watts was working on while at Genentech. The project is related to the LRRK2 gene, which is implicated in Parkinson’s disease. Many companies were working to develop drugs for it, when it was then discovered that those drugs seemed to cause lung problems in animals. Watts is of the opinion that the dosing needs to be adjusted, where the drug would block LRRK2 without causing the lung issues. Apart from this drug compound, Denali is working on others as well. On August 22, 2016, Denali filed an application in Europe to start a clinical trial in healthy volunteers for testing a new drug which is aimed at Alzheimer’s disease and Amyotrophic Lateral Sclerosis (ALS). The company is also working on drugs focused on the APOE genes. These genes are involved in the cholesterol processing in the human body and, are seen to be a key risk factor for Alzheimer’s. Denali also has a research collaboration with F-Star, a UK-based company, to deliver drugs across the blood-brain barrier that keeps medicines from getting into brain tissue.

NATCO pharma has reached a new high of Rs. 703 on the National Stock Exchange (NSE) as the drug maker revealed the successful Establishment Inspection Report (EIR) for Chennai Plant. The U.S. Food and Drug Administration (FDA) had inspected the chemical division of the Chennai facility during February 8 – February 12, 2016. The facility mainly caters to regulated international markets, including USA. The trading volumes on the counter jumped an over three-fold with a combined 938,841 shares changed hands on the BSE and NSE in the morning today.

AstraZeneca India fell by 8% today after receiving termination notice from AstraZeneca UK for termination of distribution arrangements for Meronem in India. This is a result of a global agreement by AstraZeneca PLC to sell the development and commercialization rights to Pfizer Inc, of its late-stage small molecule antibiotics business. Meronem has been one of the company’s principle products. In March 2016, it generated 18% of the total turnover of the company.

The US patent office rules in favour of Mylan, Natco Pharma’s US partner

Drugmaker Natco Pharma Ltd on Thursday said the US Patent and Trademark Office (PTO) has ruled in favour of its partner Mylan NV by striking down two patents held by Israel-based Teva Pharmaceutical Industries Ltd for its blockbuster drug Copaxone 40 mg/mL formulation. The two US patents are 8,232,250 and 8,399,413, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. Teva is now left with three more patents to fend-off generic competition for Copaxone 40 mg. Natco said the PTO’s Patent Trial and Appeal Board (PTAB) will take a decision on Mylan’s third petition seeking inter partes review of US patent number 8,969,302 by 1 September.

Mylan CEO summoned by senators for ‘urgent briefing’ on EpiPen price

Amid the social storm that Mylan has been caught in due to its increased pricing for EpiPen, Senators Susan Collins (R-ME) and Claire McCaskill (D-MO) have also tightened their belt and have called for an “urgent briefing” with Mylan CEO Heather Bresch. The meeting has been called within two weeks in order to learn the reason behind the upsurge of the pricing by about 480% since it acquired the EpiPen in 2007. The price of EpiPen in 2007 was $100, and has now increased to be over $600. Senators such as Amy Klobuchar (D-MN), Chuck Grassley (R-IA), Bernie Sanders (I-VT), and Richard Blumenthal (D-CT) have each joined in by either calling for an investigation, demanding Mylan lower the price or requesting new info.

Bristol Meyers Squibb and AbbVie have undergone an oncology clinical collaboration to develop a treatment option for patients with relapsed extensive-stage small cell lung cancer (SCLC). The collaboration is aimed to evaluate safety, tolerability and efficacy of Bristol-Myers Squibb’s Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) in combination with AbbVie’s investigational biomarker-specific antibody drug Rova-T (rovalpituuzumab tesirine) in a phase I/II clinical trial,. The combination will be tested to promote targeted cell killing and antigen release with an enhanced immunotherapy effect.

BioLineRx’s collaboration with MD Anderson Cancer Centre, Texas is set to assess the effectiveness of 2 Immunotherapies

BioLineRx is set to investigate how it’s new drug candidate, BL-8040, interacts with Keytruda (pembrolizumab), Merck’s blockbuster drug. The study will be conducted as a investigator-sponsored study, and would be a part of the clinical research that is being conducted by Merck and MD Anderson Cancer Center, as they are involved in a clinical research collaboration for studying the effect of Keytruda in combination with several other drugs and treatments. The open label Phase 2 study is expected to start later this year.

Partnership between Regeneron Pharmaceuticals and Adicet Bio may result in new treatment options for certain Cancers

A strategic collaboration and licensing agreement between Regeneron Pharmaceuticals and Adicet Bio is set to develop immune cell therapeutics like CAR T cell and TCR in several hematological and solid tumors. These companies have shared that the collaboration aims to access and improve the therapy for eliminating solid tumors through Adicet’s cell platform now under development, and innovative targeting approaches. Adicet is expected to pay an upfront payment of $25 million to Regeneron, as well as research funding over five years.

Immunotherapy Targeting Unique Mutations in a Cancer to be developed through Alliance between Amgen and Advaxis

Partnership between Amgen and Advaxis will lead to the development and commercialization of Advaxis’ Adxs-Neo, which is a potential cancer immunotherapy. This therapy is right now in its preclinical development stage. This alliance benefits from the expertise Amgen has in immuno-oncology, and Advaxis’ MINE (My Immunotherapy Neo-Epitopes) program. The MINE platform is designed to activate the immune system of the patient to respond against unique mutations present in the tumor. They will also make an upfront payment of $40 million to Advaxis, and will also purchase $25 million of Advaxis common stock. Apart from that, Amgen is said to take responsibility of funding clinical and commercial activities. Advaxis will also receive development, regulatory and sales milestone payments of up to $475 million, and will develop the Adxs-Neo through proof of concept studies.

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), a gene-editing technology, has set a record by reaching clinics from the research laboratory in a very short time, as NIH’s Recombinant DNA Advisory Committee has approved the first clinical trial of the technology in the U.S. for coming June. The trial investigators have proposed to exploit this technology to help boost cancer therapies relying on enlisting a patient’s T cells for curing the disease.

The indications that are to be investigated include melanoma, multiple myeloma, and sarcoma, and patients whose cancers have stopped responding to therapies will be enrolled. Investigators will first remove patients’ T cells, and then propose to carry out three modifications in the T cells prior to re-infusing them. Out of the three modifications, one includes expression of an affinity-enhanced T-cell receptor (TCR) that recognizes a naturally processed peptide shared by the cancer antigens NY-ESO-1 and LAGE-1. The customized TCR will be inserted into cells using a virus. CRISPR will be used to disable the existing TCR to focus the altered cells on targeting tumors instead of other non-tumor targets.

Meanwhile, we are also a witness to the patent war that is being waged between publicly held Intellia Therapeutics and CRISPR Therapeutics. At stake is whether Feng Zhang, a professor at the Broad Institute and MIT, came up with using CRISPR-Cas9 technology to edit genetic code before the team of Jennifer Doudna at UC Berkeley and Emmanuelle Charpentier of Umeå University in Sweden.

It can be thus seen that the market scenario is turning out to be quite eventful for the CRISPR Technology, and its dispute regarding who owns the right to the breakthrough gene editing technology. Its anyone’s guess on who might win, as a lot of money is riding on the patent battle. Whoever owns the rights, owns much of the money that will come out of meds approved in the future using this technology.

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